WO2020132926A1 - Méthode d'analyse d'échantillon sanguin et analyseur de coagulation sanguine - Google Patents

Méthode d'analyse d'échantillon sanguin et analyseur de coagulation sanguine Download PDF

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Publication number
WO2020132926A1
WO2020132926A1 PCT/CN2018/123800 CN2018123800W WO2020132926A1 WO 2020132926 A1 WO2020132926 A1 WO 2020132926A1 CN 2018123800 W CN2018123800 W CN 2018123800W WO 2020132926 A1 WO2020132926 A1 WO 2020132926A1
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WIPO (PCT)
Prior art keywords
detection
coagulation
optical
test object
magnetic bead
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PCT/CN2018/123800
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English (en)
Chinese (zh)
Inventor
郭文恒
章姚辉
闫华文
孙骁
Original Assignee
深圳迈瑞生物医疗电子股份有限公司
北京深迈瑞医疗电子技术研究院有限公司
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Application filed by 深圳迈瑞生物医疗电子股份有限公司, 北京深迈瑞医疗电子技术研究院有限公司 filed Critical 深圳迈瑞生物医疗电子股份有限公司
Priority to CN201880099356.1A priority Critical patent/CN112955742A/zh
Priority to PCT/CN2018/123800 priority patent/WO2020132926A1/fr
Publication of WO2020132926A1 publication Critical patent/WO2020132926A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Definitions

  • the invention relates to a medical device, in particular to a blood sample analysis method and a blood coagulation analyzer.
  • the blood coagulation analyzer is used to measure the content of various components in human blood in clinical medicine and quantify the results of biochemical analysis, providing a reliable digital basis for clinical diagnosis of various diseases in patients.
  • the measurement methods of the existing coagulation analyzer mainly include coagulation method, immunoturbidimetry method and chromogenic substrate method.
  • the coagulation method is to detect the change of a series of physical quantities (light, electricity, mechanical motion, etc.) of plasma under the action of a triggering reagent (also called coagulation activator), and then analyze the data obtained by the computer and convert it into the final result .
  • coagulation method can usually be divided into magnetic bead method and optical method, which are mainly used in prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin Time (TT) and related coagulation factor and other derivative testing.
  • PT prothrombin time
  • APTT activated partial thromboplastin time
  • FIB fibrinogen
  • TT thrombin Time
  • the magnetic bead method and the optical method are two independent detection methods that are different in detection principle and detection components
  • the current mainstream instrument manufacturers either use the magnetic bead method, such as Stargo, in the choice of the coagulation method implementation method (STAGO) companies, either using optical methods, such as Wolfen (IL) and Sysmex (SYSMEX).
  • the magnetic bead method directly uses the coagulation reaction, and the fibrinogen in the plasma is converted into fibrin, and the viscosity in the plasma is increased.
  • the test result is obtained by detecting the swing amplitude of the magnetic bead in the test cup.
  • the optical method is to use the optical principle to probe the change of the turbidity of the test sample in the test cup. Its advantage is that it can output the optical information curve in the test process, so that it can give more valuable judgments on the results and instrument status compared with the magnetic bead method.
  • the disadvantage of the optical method is that it is easily interfered by the color of the sample itself, so that the correct result cannot be obtained or the result cannot be output.
  • the horizontal axis is the wavelength (unit nm)
  • the vertical axis is the absorbance
  • the wavelength has different absorbances, reflecting that the three interferences have different absorption capabilities for light of different wavelengths, especially chyle, which has absorbance in the visible range of 340nm-790nm, which means that when the object contains When there is a large amount of chyle, irradiating the test object with visible light will absorb a large amount of light by the chyle, which will affect the results of the optical method for blood coagulation detection.
  • the invention mainly provides a blood sample analysis method and a blood coagulation analyzer.
  • the blood sample analysis method based on the blood coagulation analyzer first determines whether the sample has interference, and determines whether to use the optical method or the magnetic bead method according to the judgment result Coagulation test, which solves the problem of inaccurate optical detection or inability to output test results due to interference.
  • an embodiment provides a blood sample analysis method, including:
  • the test object contains at least the plasma of the blood sample
  • the processor controls the optical method detection device to perform the coagulation test on the test object based on the optical method;
  • the processor controls the magnetic bead method detection device to perform the coagulation detection on the test object based on the magnetic bead method.
  • an embodiment provides a blood sample analysis method based on a coagulation analyzer, including:
  • Interfering substances refer to substances that have an influence on the coagulation detection based on optical method
  • the interference information it is determined whether the blood sample to be tested is coagulated based on the optical method or the magnetic bead method.
  • an embodiment provides a coagulation analyzer including a pre-judgment device, an optical method detection device, a magnetic bead method detection device, an object transport mechanism and a processor;
  • the pre-judgment device is used to perform optical detection on the test object before performing the coagulation test under the control of the processor to obtain an optical detection result.
  • the test object contains at least the plasma of the blood sample;
  • the optical method detection device is used to perform coagulation detection on the measured object based on the optical method under the control of the processor, and output an electrical signal reflecting the coagulation situation;
  • the magnetic bead method detection device is used to perform coagulation detection on the measured object based on the magnetic bead method under the control of the processor, and output an electrical signal reflecting the coagulation situation;
  • the analyte transfer mechanism is used to transfer the reaction container containing the analyte to a preset position under the control of the processor;
  • the processor is used to determine whether the optical method detection device performs coagulation detection on the test object or the magnetic bead method detection device performs coagulation detection on the test object according to the optical detection result, and receives the electrical signal reflecting the coagulation condition, and obtains the test blood sample after processing Measurement parameters.
  • an embodiment provides an optical method detection device, a magnetic bead method detection device, a test object transport mechanism, and a processor;
  • the optical method detection device is used to perform coagulation detection on the measured object based on the optical method under the control of the processor, and output an electrical signal reflecting the coagulation situation;
  • the magnetic bead method detection device is used to perform coagulation detection on the measured object based on the magnetic bead method under the control of the processor, and output an electrical signal reflecting the coagulation situation;
  • the analyte transfer mechanism is used to transfer the reaction container containing the analyte to a preset position under the control of the processor;
  • the processor is used to obtain interference information reflecting the condition of the interference in the blood sample to be tested, and determine whether the optical method detection device performs coagulation detection on the test object or the magnetic bead method detection device performs coagulation detection on the test object according to the interference information And receive the electrical signal reflecting the coagulation situation, and obtain the measured parameters of the blood sample after processing.
  • the interfering substance refers to the substance that has an influence on the coagulation detection based on the optical method.
  • an embodiment provides a blood coagulation analyzer including: an optical method detection device, a magnetic bead method detection device, an object transport mechanism and a processor;
  • the optical method detection device is used to perform coagulation detection on the measured object based on the optical method under the control of the processor, and output an electrical signal reflecting the coagulation situation;
  • the magnetic bead method detection device is used to perform coagulation detection on the object under the control of the processor based on the magnetic bead method, and output an electrical signal reflecting the coagulation condition; the detection area of the magnetic bead method detection device and the optical method detection device are The same detection area;
  • the test object transfer mechanism is used to transfer the reaction container containing the test object to the common detection area under the control of the processor;
  • the processor is used to control the coagulation detection of the test object by the optical method detection device.
  • the optical method detection device detects inaccuracy or fails to output an electrical signal reflecting coagulation
  • the magnetic bead method detection device coagulates the test object Detection.
  • an embodiment provides a computer-readable storage medium including a program, where the program can be executed by a processor to implement the above method.
  • the blood sample analysis method and the coagulation analyzer of the above embodiment before the coagulation item test, first determine whether the sample is disturbed, and determine whether to use the optical method or the magnetic bead method to perform the coagulation item test according to the judgment result; or preferentially use the optical method Carry out blood coagulation test.
  • the optical method is used to detect the coagulation item of the sample; when the sample will affect the detection result of the coagulation test item based on the optical method, the magnetic beads are used Method for testing the blood coagulation items. This method solves the problem of inaccurate optical detection or inability to output detection results due to interference.
  • FIG. 1 is a schematic diagram of component modules of a coagulation analyzer according to an embodiment
  • FIG. 2 is a schematic structural diagram of a magnetic bead detection device according to an embodiment
  • 3a is a timing diagram of applying PWM waves to a driving coil according to an embodiment
  • FIG. 3b is a schematic diagram of an electric signal of magnetic bead movement according to an embodiment
  • FIG. 4 is a schematic structural diagram of an optical method detection device according to an embodiment
  • FIG. 5 is a spectral curve diagram of an interferer according to an embodiment
  • FIG. 6 is a schematic structural view of an embodiment where the optical method detection area and the magnetic bead method detection area are located in the same detection area;
  • FIG. 7 is a schematic diagram of multi-channel detection according to an embodiment
  • FIG. 8 is a flowchart of a blood sample analysis method according to an embodiment
  • FIG. 9 is a flowchart of an optical detection method according to an embodiment.
  • connection and “connection” mentioned in this application, unless otherwise specified, include direct and indirect connection (connection).
  • the optical method is used to detect the coagulation item of the sample; when the sample will affect the detection result of the coagulation test item based on the optical method, the magnetic beads are used Method for testing the blood coagulation items.
  • FIG. 1 shows a schematic structural diagram of a blood coagulation analyzer according to an embodiment of the present invention.
  • the blood coagulation analyzer includes a sample placement area 11, a sample collection mechanism 12, a reagent placement area 13, a reagent collection mechanism 14, and a reaction vessel
  • the placement area 10 the object transfer mechanism 15, the pre-judgment device 16, the optical method detection device 18, the magnetic bead method detection device 17, and the processor 19.
  • the sample placement area 11 is used to provide a place where the test sample 11a is placed.
  • the test sample may be plasma after removing blood cells, for example, plasma obtained by centrifuging the blood sample.
  • the sample placement area 11 is a rectangular area where multiple samples 11a can be placed. In an actual instrument, the sample placement area 11 may also be a bar-shaped or circular area, or it may be only a location where the sample is placed.
  • the reagent placement area 13 is used to provide a place where the test reagent 13a is placed.
  • the reagent placement area 13 is a rectangular area in which multiple test reagents 13a can be placed. In an actual instrument, the reagent placement area 13 may also be a bar or circular area.
  • the reagent includes at least one of a diluent, a mixed reagent, and a trigger reagent.
  • the reaction container placement area 10 is used to provide a place for placing the test reaction container 10a.
  • the reaction vessel placement area 10 is a rectangular area, and a plurality of reaction vessels 10a can be placed. In an actual instrument, the reaction vessel placement area 10 may also be a bar or circular area.
  • the sample collection mechanism 12 is used to collect the tested sample from the sample placement area 11 and add the measured sample to the reaction container 10a placed on the reaction container placement area 10
  • the reagent collection mechanism 14 is used to collect the reagent from the reagent placement area 13 And add the reagent to the reaction container 10a placed on the reaction container placement area 10.
  • the sample to be tested and the reagent are mixed and reacted in the reaction vessel 10a to form a sample.
  • the sample collection mechanism 12 and the reagent collection mechanism 14 may also be two-dimensional moving parts with a sampler, which can be collected in the sample placement area 11 or the reagent placement area 13 by two-dimensional movement in the plane
  • the tested sample or reagent is added to the reaction container 10a placed on the reaction container placement area 10.
  • the reaction container placement area 10 also has the function of incubation.
  • the sample to be tested and the reagent are mixed in the reaction container 10a and then placed on the reaction container placement area 10 for incubation. After the incubation is completed, the test object The transfer mechanism 15 transfers to the corresponding detection position for detection.
  • the reaction container placement area 10 does not have an incubation function. After the test sample and the reagent are mixed in the reaction container 10a, the test object transport mechanism 15 needs to be transferred to the incubation position for incubation.
  • the magnetic bead method detection device 17 is used to detect the coagulation item based on the magnetic bead method on the sample (analyte) mixed with the test sample and the reagent under the control of the processor, and output an electrical signal reflecting the coagulation condition to the processing ⁇ 19 ⁇ 19.
  • the area where the sample is tested for coagulation based on the magnetic bead method is called the magnetic bead method detection area.
  • the structure of the magnetic bead method detection device 17 is shown in FIG. 2, which may include a driving coil 210 and a measurement coil 220.
  • the structure of the reaction vessel used in the magnetic bead method is shown in FIG. 2.
  • the reaction container 200 is subjected to a cross-sectional process.
  • a magnetic bead 201 is placed in the accommodating chamber of the reaction container 200, and the bottom of the reaction container is provided for the magnetic bead 201 to move under the drive of a magnetic field.
  • the reaction container 200 has a length direction extending along the motion track of the magnetic beads and a width direction perpendicular to the length direction.
  • the magnetic bead is made of a material that can be quickly magnetized and demagnetized.
  • the magnetic bead When the magnetic bead is in a magnetic field, it can be quickly magnetized by the magnetic field. When the magnetic field disappears, the magnetic bead can be quickly demagnetized.
  • the shape of the magnetic bead may be spherical or other shapes, such as a polyhedron, which are only exemplified here and not specifically limited.
  • the detection device 16 may include an even array of drive coils 210, for example, there may be two sets of drive coils 210, and the two sets of drive coils 210 are located opposite each other at a certain distance, and are located on both sides of the reaction vessel 200 along the length of the reaction vessel 200, respectively. .
  • the two driving coils 210 are applied with PWM waves of the same period but different timing. As shown in FIG.
  • the period M1 and the period M2 are the periods during which the driving coil M1 and the driving coil M2 generate magnetic fields, respectively, thereby generating intermittent magnetic fields alternately (in During the period t1 and t2, the driving coil M1 generates a magnetic field in the illustrated period M1; during the period t3 and t4, the driving coil M2 generates a magnetic field in the illustrated period M2; and so on), the magnetization is repeated by the magnetic field
  • the beads cause the magnetic beads 201 in the reaction container 200 to oscillate along the orbit formed by the reaction container.
  • the detection device 16 may include an even-numbered array of measurement coils 220, for example, may include two sets of measurement coils 220, and the two sets of measurement coils 220 are located opposite each other at a certain distance, and are located on both sides of the reaction vessel 200 along the width direction of the reaction vessel 200, respectively. .
  • the two sets of measuring coils 220 are divided into a transmitting coil and a receiving coil.
  • the two ends of the transmitting coil are connected to a signal transmitting circuit (not shown in the figure), which is used to input a sine wave alternating current and used to generate a continuous magnetic field.
  • the two ends of the receiving coil are connected A signal receiving circuit (not shown in the figure) to detect the motion electrical signal generated by the oscillating motion of the magnetic bead 201.
  • the movement electrical signal refers to an electrical signal that can reflect the movement state of the magnetic bead 201.
  • the transmitting coil generates a magnetic field, and the magnetic beads cut the magnetic field lines to change the path of the magnetic field lines, thereby changing the magnetic flux received by the receiving coil.
  • the receiving coil generates the original induced electromotive force according to the received magnetic flux to generate a corresponding induced current.
  • the induced current undergoes circuit conversion and signal Conditioning can obtain a voltage signal containing motion information of the magnetic bead 201, that is, a motion electrical signal of the magnetic bead 201. Since the motion of the magnetic bead 201 changes the characteristics of the original induced current, the motion information of the magnetic bead 201 can be extracted from the changed induced current.
  • two sets of driving coils 210 and two sets of measuring coils 220 are arranged to cross each other, and the reaction vessel 200 is between two sets of driving coils 210 and at the same time between two sets of measuring coils 220.
  • the magnetic beads 201 can move in the sample to be tested in the reaction container 200.
  • the measuring coil 220 When the magnetic bead 201 moves in the reaction vessel 200, the measuring coil 220 generates a corresponding induced current, which reflects the movement of the magnetic bead 201 and can be used as the motion electrical signal of the magnetic bead 201.
  • the induced current generated by the measuring coil 220 may be converted to obtain a voltage signal, and the voltage signal may be used as the motion electrical signal of the magnetic bead 201.
  • the measurement coil 220 transmits the motion electric signal of the magnetic bead 201 obtained by the detection to the processor.
  • the measurement coil 220 may be connected to the processor through a signal conversion circuit (not shown) and a signal conditioning circuit (not shown).
  • the signal conversion circuit can perform analog-to-digital conversion on the motion electrical signal of the magnetic bead 201 acquired by the measuring coil 220 for at least a period of time
  • the signal conditioning circuit can be capable of converting the magnetic bead 201 acquired by the measurement coil 220 for at least a period of time.
  • the motion electric signal is preprocessed such as rectification, filtering and normalization. FIG.
  • 3b is a schematic diagram of the movement electrical signal of the magnetic bead 201 in a period of time in an embodiment, wherein the movement electrical signal of the magnetic bead 201 may be a voltage signal.
  • the magnetic bead 201 is in the reaction vessel Reciprocating motion within 200, the electric signal of the magnetic bead 201 in a period of time presents a sinusoidal distribution, as shown in the figure.
  • the optical method detection device 18 is used to detect the coagulation item based on the optical method of the sample (analyte) mixed with the test sample and the reagent under the control of the processor 19, and output an electrical signal reflecting the coagulation condition to the processor 19.
  • the area where the sample is tested for coagulation based on the optical method is called the optical detection area.
  • the structure of the optical method detection device 400 is shown in FIG. 4, and may include a light source 410 for performing optical method detection, a lens assembly 420, a filter 430 and a receiving unit 450.
  • a halogen lamp may be used as the light source 410.
  • the halogen lamp is accommodated in a lamp case having a plurality of heat sinks.
  • the heat sinks are used to cool the heat generated by the light source 410 due to heat generation.
  • the lens assembly 420 is composed of a plurality of condensers, and is used to converge and collimate the scattered light emitted by the light source 410.
  • the lens assembly 420 is disposed on the optical path that guides the light irradiated by the light source 410 to the sample 440 (object to be measured).
  • the filter 430 may be a disc shape, a polygon, etc. In a preferred embodiment, the filter 430 is a disc shape, which can be rotated around the center of the circle under the drive of a motor .
  • the filter 430 is provided with a plurality of holes. In one embodiment of the present application, six holes are provided on the filter 430 as an example for description. For other cases, refer to this embodiment for the same or similar applications. As shown in the figure, the hole 431 is a hole to block the opaque light, and the remaining five holes 432 are used to install five filters with different transmission wavelengths.
  • the five filters only transmit 340nm, 405nm, and 575nm, respectively , 660nm and 800nm light, other wavelengths of light are not transmitted, the hole 431 can be a spare hole, only need to add an optical film before installing the optical film.
  • the 6 holes are provided along the rotation direction of the filter 430 at a certain angular interval. With the rotation of the filter 430, the filter can be rotated to the optical path, so that the light only passes through the filter after passing through the filter Only the light with the matching wavelength of the film can pass through and illuminate the reaction container behind for optical detection.
  • the prothrombin time (PT) test item requires 405nm wavelength light to illuminate the sample, so The processor controls the motor to rotate the 405 nm wavelength filter on the filter 430 onto the optical path.
  • the thrombin time (TT) test item requires 660nm wavelength light to illuminate the sample, so the processor controls the motor to rotate the 660nm wavelength filter on the filter 430 to the optical path.
  • the receiving unit 450 is connected to the processor.
  • the receiving unit 450 is used to collect transmitted light and/or scattered light after the sample is irradiated with light of a specific wavelength, convert the optical signal into an electrical signal, and transmit the electrical signal to the processor. After the processor processes the electrical signal, the measurement parameters of the blood sample to be measured are obtained.
  • the optical method detection device 400 may not use the above halogen lamp solution, but adopt LEDs with multiple wavelengths, and combine the beams emitted by the multiple LEDs through a dichroic mirror corresponding to the LEDs.
  • a light combining prism is used to combine multiple wavelength beams, that is, the detection structure or detection method of the optical method detection device 400 is not limited, and details are not described herein again.
  • Fig. 5 is an exemplary hemoglobin, bilirubin, chyle and other interfering substances spectral curve, the horizontal axis is the wavelength (unit nm), the vertical axis is the absorbance, the inventor noticed that the three substances are different
  • the wavelength has different absorbances, reflecting that the three interferences have different absorption capabilities for light of different wavelengths, especially chyle, which has absorbance in the visible range of 340nm-790nm, which means that when the object contains When there is a large amount of chyle, irradiating the test object with visible light will absorb a large amount of light by the chyle, which will affect the results of coagulation detection based on the optical method.
  • a pre-judgment link is added before the formal coagulation test is performed to determine whether the sample to be tested contains an interferer that has an effect on the coagulation detection result based on the optical method.
  • the pre-judgment device 16 is used to perform optical detection on the test object before performing coagulation detection under the control of the processor 19 to obtain an optical detection result.
  • the test object detected by the pre-judgment device 16 contains at least the test sample, that is, the test object may be plasma, or a mixture of plasma and reagent (sample), and the reagent includes at least the diluent, mixed reagent, and trigger reagent.
  • the detection position where the pre-judgment device 16 optically detects the object may be a dedicated position, or may be an incubation area, an optical method detection area, or a magnetic bead method detection area.
  • the pre-judgment device 16 includes a photodetection device, and the photodetection device includes a light emitting end and a light receiving end, wherein the light emitting end is used to adopt at least one kind of specific wavelength light or the wavelength is close to the specific wavelength
  • the specific light refers to the wavelength of light used when the coagulation item is detected by the optical method.
  • the light receiving end is used to detect the optical information of the light of the test object after being subjected to light, to obtain the optical detection result of the test object for light of each specific wavelength.
  • the optical information may be the transmitted and/or scattered light intensity after the light beam passes through the measured object.
  • the light receiving end is signally connected to the processor 19, and is used to send the obtained optical detection result to the processor 19.
  • the light emitting end of the pre-judgment device 16 is connected to the optical method detection device, and the light beam that irradiates the object to be measured is the light beam that is filtered by the filter 430 and then split through the optical fiber; when the pre-judgment When the detection position where the device 16 optically detects the object is the optical detection area, the light filtered by the corresponding light-transmitting filter 430 can be directly irradiated to the object without a separate light source.
  • the light emitting end of the pre-judgment device 16 may also have a separate light source.
  • the pre-judgment device 16 includes an image acquisition device, the image acquisition device is used to collect image data (such as photos) of the object to be measured, to obtain an optical detection result, and send the optical detection result to the processor 19.
  • the image acquisition device may be a camera for capturing image data.
  • the processor 19 is used to obtain the interference information reflecting the condition of the interference in the blood sample to be tested, and to determine whether the optical method detection device performs coagulation detection on the test object or the magnetic bead method detection device performs coagulation on the test object based on the interference information Detect and receive the electrical signal reflecting the coagulation situation, and then process the electrical signal to obtain the measurement parameters of the blood sample to be measured.
  • the interfering substance refers to the substance that has an influence on the coagulation detection based on the optical method.
  • the processor 19 obtains interference information reflecting the condition of the interference in the test object according to the optical detection result.
  • the light emitting end of the pre-judgment device 16 is irradiated with light of at least one specific wavelength
  • the test object receives the transmitted light and/or scattered light of the test object after being irradiated with light
  • the processor 19 calculates the test object for each specific wavelength of light based on the optical information received from the light receiving end of the pre-judgment device 16
  • the absorbance value of at least one specific wavelength light is greater than the preset threshold value, it means that the sample will absorb the specific wavelength light, and the interference in the test object will be detected by the optical method for the detection of blood coagulation.
  • the preset threshold has different values for different specific wavelengths of light, which may be the system default setting value, or a value set by the user based on experience or experimental data.
  • the processor controls the optical method detection device to perform coagulation detection on the object based on the optical method; when the interference in the object will affect the detection result of the coagulation detection item based on the optical method, or
  • the processor controls the magnetic bead method detection device to perform coagulation detection on the object based on the magnetic bead method.
  • the interfering substance refers to a substance that absorbs light of a specific wavelength, wherein the specific wavelength refers to at least one
  • the test object may be irradiated with light close to a specific wavelength, and it may also be determined whether there is an interfering substance that will affect the detection result of the coagulation test item based on the optical method.
  • the processor 19 recognizes the color of the test object based on the image data (such as a photo) received from the pre-judgment device 16 and compares the color of the test object with the preset color.
  • the preset color is the color of the image data obtained when there is no interference in the test object, which can be the default color set by the system or the color set by the user based on experience or experimental data.
  • the processor controls the optical method detection device to perform coagulation detection on the test object; when the test object When the interfering substance in the test will affect the detection result of the coagulation detection item based on the optical method, the processor controls the magnetic bead method detection device to perform coagulation detection on the test object.
  • the optical detection area based on the optical method for coagulation detection and the magnetic bead detection area based on the magnetic bead method are the same detection area.
  • the reaction container used for the magnetic bead method for coagulation detection is the same device as the container for holding the sample which is used for the optical method for coagulation detection.
  • the magnetic beads need to be placed at the bottom of the reaction vessel.
  • the magnetic beads move under the drive of the driving coil, and the measurement coil obtains the movement of the magnetic beads according to the generated induced electromagnetic field.
  • the generated electrical signals are sent to the processor; when using the optical method for coagulation detection, there is no need to place magnetic beads in the reaction vessel, and the emission fiber uses at least one light of a specific wavelength or a light pair with a wavelength close to a specific wavelength
  • the test object in the reaction vessel is irradiated, and the receiving optical fiber transmits the received light information to the photoelectric conversion unit to obtain an electric signal.
  • the magnetic beads can only be placed in the reaction container when the magnetic bead method is used for detection, and there are no magnetic beads in the reaction container when the optical method is used for detection.
  • the coagulation analyzer also includes Pick-and-place device; of course, in some embodiments, the magnetic beads can always be placed in the reaction vessel. When performing optical detection, the magnetic beads will always remain at the bottom of the reaction vessel. In this case, the coagulation analyzer does not need to be used for pick-and-place Magnetic bead pick and place device.
  • the analyzer may also be provided with multiple detection areas as shown in FIG. 6 for detecting multiple samples at the same time, and each detection area may share an optical irradiation unit ,
  • the beam is directed to each detection area by a beam splitter to illuminate each object to be measured. If the position where the pre-judgment device performs optical detection on the object is not in this area, the beam can also be directed to the optical detection position (for example, dedicated position, incubation area, etc.) through the beam splitter.
  • the coagulation analyzer may not include a pre-judgment device, and the pre-judgment result of the sample to be tested may come from other modules connected online, that is, to obtain information reflecting the condition of interfering substances in the blood sample to be tested.
  • the information of interfering substances can come from other on-line instruments, and there is no need to install a pre-judgment device on the coagulation analyzer.
  • the optical method detection device detects inaccuracy or fails to output an electrical signal reflecting coagulation
  • the magnetic bead method detection device performs coagulation detection on the test object.
  • the blood coagulation analyzer in the above embodiments of the present application is mainly used for performing blood coagulation analysis on the test object.
  • the blood coagulation analyzer in the present application can use an optical method detection device to measure the object based on the optical method.
  • the magnetic bead method detection device can be used for the coagulation detection of the analyte based on the magnetic bead method.
  • the optical method can output the optical information curve in the test process, so that the result and the state of the instrument can be given more valuable judgment than the magnetic bead method, so the optical method is preferred in practical applications.
  • the magnetic bead method is used to detect the coagulation item, which can avoid the influence of the interfering substances on the coagulation detection results based on the optical method.
  • the blood sample analysis method of pre-judging the test object and then performing coagulation analysis includes the following steps:
  • Step 801 Start the blood sample analysis program of the coagulation analyzer.
  • Step 802 Obtain the test item for the blood sample to be tested, and determine whether the test item is a coagulation method item. If the test item is a coagulation method item, perform step 803. If the test item is not a coagulation method item, perform step 807. Select another method. The test object is tested and the test result is output.
  • Step 803 Perform optical detection on the test object contained in the reaction container to obtain an optical detection result, and obtain interference information reflecting the situation of the interference in the test object according to the optical detection result.
  • the specific wavelength used in the subsequent coagulation item test using the optical method can be known.
  • the specific wavelength is used one by one to the test objects contained in the reaction vessel Light irradiation, and collect the transmitted light and/or scattered light of the test object after light irradiation.
  • the test object contains at least the plasma of the blood sample to be tested, and the test object in this step may be plasma or a mixture of plasma and reagent.
  • the absorbance caused by the cascade reaction changes little at this time. Therefore, if this period of time is analyzed, the absorbance data of the sample can be obtained substantially accurately, so that the condition of the interfering substance can be judged.
  • a more obvious luminous flux baseline period will be formed.
  • the analyte undergoes a cascade of coagulation factors, so its luminous flux changes little and the luminous flux curve is flat.
  • the detected absorbance data is only the superposition of the absorbance data of the sample and the reagent absorbance data. Since the reagent absorbance data is known, the absorbance data of the sample to be tested can be obtained, so that the interference can be determined.
  • the luminous flux of the test sample is basically unchanged.
  • the absorbance data of the test sample before the trigger reagent is added is only the test sample and Superimposition of absorbance data of diluent and mixed reagent. Since the absorbance data of the diluent and mixed reagents are known, the absorbance data of the tested sample can be obtained, so that the condition of the interfering substances can be judged.
  • the diluent and mixed reagent are added first, followed by the trigger reagent. In some coagulation tests, it may not be necessary to add diluent and mixed reagents.
  • the process of optical detection of the measured object in this embodiment includes the following steps 901-903:
  • Step 901 Irradiate the test object with light of at least one wavelength.
  • the sample is irradiated with light of a specific wavelength to obtain optical information of scattered light and/or transmitted light after the beam irradiates the sample.
  • the setting time is set according to the type of reagent added to the sample to be tested and the time of adding the reagent.
  • the light beam comes from the optical method detection device. In another embodiment, it may also be a light source unique to the prediction device.
  • Step 902 Detect the optical information of the test object after being subjected to light.
  • the optical information includes the absorbance information of the test object.
  • the absorbance information is mainly the superposition of the absorbance data of the test sample and the absorbance data of the reagent. If the absorbance data of the reagent itself is subtracted from the absorbance information of the test sample, the measured value can be obtained.
  • the absorbance data of the sample Generally, the pre-judgment device detects the luminous flux data, where the luminous flux data includes the luminous flux data of the transmitted light and/or scattered light, and then the absorbance information is determined according to the luminous flux data and the initial luminous flux of the light source, and the absorbance information can be obtained according to the luminous flux data . Therefore, the optical information may also include luminous flux data of scattered light and/or transmitted light after the light beam illuminates the object.
  • interfering substances such as chyle, hemoglobin, and bilirubin have their own absorption spectra, they can be irradiated with multiple beams of different wavelengths. After irradiated with beams of each wavelength, they can be judged according to the absorbance value of the measured substance.
  • the situation of the corresponding interference for example, whether it contains interference.
  • light beams of various wavelengths can be used to irradiate the object to be measured, and the light beams of each wavelength correspond to three kinds of interfering substances, such as chyle, hemoglobin, and bilirubin, so that the corresponding interfering substances can be judged according to the absorbance values of the light beams of each wavelength. Therefore, in one of the embodiments, more than one wavelength beam is used to illuminate the object.
  • Step 903 Obtain the optical detection result of the test object according to the optical information.
  • the absorbance value of the test object for each specific wavelength of light is calculated.
  • the preset threshold value is obtained based on the predicted absorbance information of the reagent, the predicted absorbance information of the measured sample without interference, and the predicted ratio information of the tested sample and the reagent.
  • the absorbance information of the reagent and the ratio information of the sample to be tested and the reagent can be obtained from the setting information or detection parameters of the instrument, so it is foreseeable.
  • the ratio information may be volume ratio information or weight ratio information.
  • the optical detection further includes: collecting image data (such as a photo) of the measured object, obtaining color information based on the image data, and obtaining interference information reflecting the condition of the interference in the measured object according to the color information to obtain Optical inspection results.
  • image data such as a photo
  • interference information reflecting the condition of the interference in the measured object according to the color information to obtain Optical inspection results.
  • the prompt information and/or the alarm information may also be issued according to the interference in the tested sample.
  • the prompt information and/or the alarm information may include: Prompt information and/or warning information of the interference in the system, or prompt information that determines to use the optical method or the magnetic bead method.
  • step 804 may be performed.
  • Step 804 According to the interference information, determine whether it will affect the detection result of the coagulation detection item based on the optical method, and determine the coagulation detection method used for the blood sample to be tested.
  • Step 806 is executed when the detection result of the coagulation detection item has an influence
  • step 805 is executed when the interference in the test object has an influence on the detection result of the coagulation detection item based on the optical method.
  • Step 805 The processor controls the magnetic bead method detection device to perform coagulation detection on the test object based on the magnetic bead method, output an electrical signal reflecting the coagulation status, and process the electrical signal to obtain the measurement parameters of the blood sample to be measured.
  • Step 806 The processor controls the optical method detection device to perform coagulation detection on the test object based on the optical method, output an electrical signal reflecting the coagulation status, and process the electrical signal to obtain the measurement parameters of the blood sample to be measured.
  • the method of step 803 may not be used for optical detection of the test object, but the optical method detection device may be used for direct detection of the blood coagulation of the test object.
  • the detection device detects inaccuracy or fails to output an electrical signal reflecting the coagulation situation, the magnetic bead method detection device is then used to detect the coagulation of the test object.
  • the present application also provides a coagulation analyzer according to an embodiment, which is used to measure and analyze the number of specific substances related to blood coagulation/fibrinolysis function and the degree of activity thereof, and the specimen is plasma.
  • the coagulation analyzer of the present embodiment measures the specimen by the clotting time method, the chromogenic substrate method, and the immunoturbidimetric method.
  • the coagulation time method used in this embodiment is a measurement method that uses the coagulation process of a specimen as a change in transmitted light detection or a motion change of a magnetic bead in a specimen driven by a magnetic force.
  • the measurement items of the clotting time method include PT (prothrombin time), APTT (activated partial thrombin time), TT (thrombin time), and FIB (fibrinogen amount).
  • the measurement items of the chromogenic substrate method include AT-III (antithrombin III), etc.
  • the measurement items of the immunoturbidimetric method include D-Dimer (D-dimer) and FDP.
  • any tangible, non-transitory computer-readable storage medium can be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROM, DVD, Blu Ray disks, etc.), flash memory, and/or the like .
  • These computer program instructions can be loaded onto a general purpose computer, special purpose computer, or other programmable data processing equipment to form a machine, so that these instructions executed on a computer or other programmable data processing device can generate a device that implements a specified function.
  • Computer program instructions can also be stored in a computer-readable memory, which can instruct the computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory can form a piece Manufactured products, including implementation devices that implement specified functions.
  • Computer program instructions can also be loaded onto a computer or other programmable data processing device, so that a series of operating steps are performed on the computer or other programmable device to produce a computer-implemented process that allows the computer or other programmable device to execute Instructions can provide steps for implementing specified functions.

Abstract

La présente invention concerne une méthode d'analyse d'échantillon sanguin et un analyseur de coagulation sanguine. La méthode d'analyse d'échantillon sanguin reposant sur l'analyseur de coagulation sanguine consiste à : effectuer une détection optique d'un objet à détecter contenu dans un récipient de réaction pour obtenir un résultat de détection optique, l'objet à détecter comprenant au moins le plasma d'un échantillon sanguin à détecter ; obtenir des informations d'interférents reflétant les interférents dans l'objet à détecter sur la base du résultat de détection optique (803) ; déterminer une méthode de détection de coagulation sanguine de l'échantillon sanguin à détecter sur la base des informations d'interférents (804) ; lorsque les interférents compris dans l'objet à détecter n'influencent pas un résultat de détection d'un élément de détection de coagulation sanguine sur la base d'une méthode optique, appliquer une détection de coagulation sanguine à l'objet à détecter sur la base de la méthode optique (806) ; et, lorsque les interférents compris dans l'objet à détecter influencent le résultat de détection de l'élément de détection de coagulation sanguine sur la base de la méthode optique, appliquer la détection de coagulation sanguine à l'objet à détecter sur la base d'une méthode faisant appel à des billes magnétiques (805).
PCT/CN2018/123800 2018-12-26 2018-12-26 Méthode d'analyse d'échantillon sanguin et analyseur de coagulation sanguine WO2020132926A1 (fr)

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